At a glance
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Phase 2 Pilot Study to Evaluate Efficacy and Safety of Anakinra to Prevent CD19-Targeted CAR-T Cell-Related Cytokine Release Syndrome (CRS) and Neurotoxicity in Patients With B Cell Lymphoma
In Brief
A Phase 2 clinical trial evaluating Anakinra, X-Ray Imaging, and 6 other interventions for B-Cell Non-Hodgkin Lymphoma. Completed, enrolled 27 participants across 1 site.
Detailed Summary
This phase II trial studies how well anakinra works in decreasing the occurrence of cytokine release syndrome (CRS) and damage to the nerves (neurotoxicity) in patients with B-cell non-Hodgkin lymphoma who are receiving CD-19 targeted chimeric antigen receptor T-cell (CAR-T) therapy. CAR-T cell therapy may be complicated by two potentially life-threatening side effects: CRS and neurotoxicity. Anakinra is a drug typically used to treat rheumatoid arthritis, but may also help in preventing CAR-T cell-related cytokine release syndrome and neurotoxicity.
Study Details
Timeline
Interventions
Given IV (previously SC)
Undergo x-ray
Undergo PET/CT
Undergo PET/CT or CT
Undergo BMA
Undergo bone marrow biopsy
Undergo lumbar puncture
Undergo blood sample collection